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Study flow diagram.
Figuras y tablas -
Figure 1

Study flow diagram.

Table 1. Type of intervention: intravenous tocilizumab treatment versus standard treatment. Type of studies: randomised controlled trials

Outcomes

Measure

Relative effect

Number of participants
(studies)

Quality of evidence
(GRADEa)

Comments

Change in TED as defined by investigators

Measured in CAS/EUGOGO/NOSPECS/VISA classification at 12 months (range 6–18 months) post treatment

Change in proptosis

Measured in millimetres at 12 months (range 6–18 months) post treatment

Change in extraocular motility

Measured in degrees at 12 months (range 6–18 months) post treatment

Number of relapses

Per participant at 12 months (range 6–18 months) post treatment

Development of optic neuropathy

As defined by the trial investigators at 12 months (range 6–18 months) post treatment

Change in quality‐of‐life score

GO‐QOL score or EQ‐5D score at 12 months (range 6–18 months) post treatment

MCID = 6 points

Adverse effects

Any adverse effect that is reported at 12 months (range 6–18 months) post treatment

aThe GRADE approach defines the quality of a body of evidence as the extent to which one can be confident that an estimate of effect or association is close to the quantity of specific interest. Certainty of a body of evidence involves consideration of within‐study risk of bias (methodological quality), directness of evidence, heterogeneity, precision of effect estimates and risk of publication bias.
CAS: Clinical Activity Score; EQ‐5D: European Quality of life questionnaire; EUGOGO: European Group On Graves' Orbitopathy; GO‐QOL: Graves' Orbitopathy Quality of Life questionnaire; MCID: minimal clinically important difference; NOSPECS: No symptoms or signs, Only signs, Soft tissue involvement, Proptosis, Extraocular muscle involvement, Corneal involvement and Sight loss. It is graded as 0, a, b or c; TED: thyroid eye disease; VISA: Vision, Inflammation, Strabismus, and Appearance classification.
We planned to express the treatment effect for each continuous outcome as a mean difference with 95% confidence interval (CI). Where continuous outcomes were measured using different scales, we planned to express the treatment effect as a standardised mean difference with 95% CI.

Figuras y tablas -
Table 1. Type of intervention: intravenous tocilizumab treatment versus standard treatment. Type of studies: randomised controlled trials
Table 2. Type of intervention: intravenous tocilizumab treatment versus placebo. Type of studies: randomised controlled trials

Outcomes

Measure

Relative
effect

Number of participants
(studies)

Quality of evidence
(GRADEa)

Comments

Change in TED as defined by investigators

Measured in CAS/EUGOGO/NOSPECS/VISA classification at 12 months (range 6–18 months) post treatment

Change in proptosis

Measured in millimetres at 12 months (range 6–18 months) post treatment

Change in extraocular motility

Measured in degrees at 12 months (range 6–18 months) post treatment

Number of relapses

Per participant at 12 months (range 6–18 months) post treatment

Development of optic neuropathy

As defined by the trial investigators at 12 months (range 6–18 months) post treatment

Change in quality‐of‐life score

GO‐QOL score or EQ‐5D score at 12 months (range 6–18 months) post treatment

MCID = 6 points

Adverse effects

Any adverse effect that is reported at 12 months (range 6–18 months) post treatment

aThe GRADE approach defines the quality of a body of evidence as the extent to which one can be confident that an estimate of effect or association is close to the quantity of specific interest. Certainty of a body of evidence involves consideration of within‐study risk of bias (methodological quality), directness of evidence, heterogeneity, precision of effect estimates and risk of publication bias.
CAS: Clinical Activity Score; EQ‐5D: European Quality of life questionnaire; EUGOGO: European Group On Graves' Orbitopathy; GO‐QOL: Graves' Orbitopathy Quality of Life questionnaire; MCID: minimal clinically important difference; NOSPECS: No symptoms or signs, Only signs, Soft tissue involvement, Proptosis, Extraocular muscle involvement, Corneal involvement and Sight loss. It is graded as 0, a, b or c; TED: thyroid eye disease; VISA: Vision, Inflammation, Strabismus, and Appearance classification.
We planned to express the treatment effect for each continuous outcome as a mean difference with 95% confidence interval (CI). Where continuous outcomes were measured using different scales, we planned to express the treatment effect as a standardised mean difference with 95% CI.

Figuras y tablas -
Table 2. Type of intervention: intravenous tocilizumab treatment versus placebo. Type of studies: randomised controlled trials